Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304538
Status:
COMPLETED
Last Update Posted:
2006-08-23
First Post:
2006-03-16
Brief Title:
A Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamic Activity of Very Low Dose-Glucagon in Subjects With Type 1 Diabetes Mellitus
Sponsor:
DiObex
Organization:
DiObex
Study Overview
Official Title:
A Phase 1b Single-Blind Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamic Activity of Three Separate Dose Levels of Very Low Dose-Glucagon Administered Subcutaneously Overnight for 6 9 or 12 Hours in Subjects With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify the safest dose of very low dose glucagon to prevent hypoglycemia in patients with Type I diabetes who use insulin pumps and to measure the the amount of glucagon in the blood and see how the body responds to the glucagon
Detailed Description:
Glucagon is currently used to treat severe hypoglycemia DiObex believes that glucagon replacement therapy with very low doses of glucagon may prevent hypoglycemia without compromising effective glycemic control by insulin In this study very low doses of glucagon will administered to Type I diabetics who use insulin pumps The glucagon will be administered subcutaneously overnight for 6 9 or 12 hours to see if the number of mild or impending hypoglycemia events can be safely decreased Three different doses of glucagon will be compared to a control infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None